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March
19

Comment Deadline: FDA Draft Guidance for Drug Products Containing Nanomaterials

  • Agency
  • Industry
  • Nanotechnology

The Food and Drug Administration (FDA) is seeking public comments regarding its draft guidance documents for applicants with drug products that contain nanomaterials. The FDA acknowledges that it evaluates nanomaterial-containing drug products on a case-by-case basis and uses a risk-based approach.  The FDA clarifies how applicants should approach nanomaterial analyses and integrate their findings throughout manufacturing processes and product development.

March
16

Comment Deadline: FDA Opioid Policy Steering Committee – Prescribing Intervention—Exploring a Strategy for Implementation

  • Government
  • Agency
  • Neuroscience

The Food and Drug Administration (FDA) is seeking public comments for its public hearing entitled, “Opioid Policy Steering Committee: Prescribing Intervention—Exploring a Strategy for Implementation.”

March
5

Request for comment: Regulatory barriers in the Federal Motor Vehicle Safety Standards (FMVSS)

  • Government
  • Agency
  • Robotics/AI

NHTSA seeks public comments to identify any regulatory barriers in the existing Federal Motor Vehicle Safety Standards (FMVSS) to the testing, compliance certification and compliance verification of motor vehicles with Automated Driving Systems (ADSs).

March
4

Comment Deadline: EFSA Draft Guidance on the Risk Assessment of Nanotechnology Applications in the Food and Feed Chain: Part 1, Human and Animal Health

  • Agency
  • Industry
  • Nanotechnology

The European Food Safety Authority (EFSA) is seeking public comments regarding the first part of its updated draft guidance for applications in which nanoscience or nanotechnology are integrated into the food and feed chain.

February
16

Comment Deadline: FDA Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease

  • Government
  • Agency
  • Genetics/Genomics

The Food and Drug Administration (FDA) is announcing the availability of and soliciting public comments on a draft guidance for industry entitled “Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease.”

February
15

Comment Deadline: FDA Evaluation of Devices Used With Regenerative Medicine Advanced Therapies

  • Government
  • Agency
  • Statute
  • Genetics/Genomics

The Food and Drug Administration (FDA) is announcing the availability of and soliciting public comments on a draft document entitled “Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Draft Guidance for Industry.”

February
15

Comment Deadline: FDA Expedited Programs for Regenerative Medicine Therapies for Serious Conditions

  • Government
  • Agency
  • Genetics/Genomics

The Food and Drug Administration (FDA) is announcing the availability of and soliciting public comments on a draft document entitled “Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry.”

February
12

Comment Deadline: FDA Packaging, Storage, and Disposal Options To Enhance Opioid Safety—Exploring the Path Forward

  • Government
  • Agency
  • Neuroscience

The Food and Drug Administration (FDA) is soliciting public comments for the upcoming public workshop entitled “Packaging, Storage, and Disposal Options To Enhance Opioid Safety—Exploring the Path Forward.”

February
9

Comment Deadline: NIH All of Us Research Program Priorities

  • Government
  • Agency
  • Genetics/Genomics

The National Institutes of Health (NIH) is seeking public input that outlines and describes research questions that the All of Us Research Program could help answer. The submitted information will be used at the All of Us Research Priorities Workshop on March 21 – 23, 2018, to identify key research priorities and requirements (such as data types and methods) for future versions of the All of Us protocol.

February
9

Comment Deadline: USDA Petition for Determination of Nonregulated Status of Canola Genetically Engineered for Altered Oil Profile

  • Government
  • Agency
  • Genetics/Genomics

The Animal and Plant Health Inspection Service (APHIS), within the United States Department of Agriculture (USDA), is seeking public comment on a petition it received from Nuseed Americas Inc. seeking a determination of nonregulated status of canola designated as event B0050-027, which has been genetically engineered to accumulate the long chain omega-3 fatty acid known as docosahexaenoic acid in seed.

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